Application for Investigational Human-Use of
Radioisotopes/Radiographic machines
Fill out completely, use supplemental pages if
necessary, and return with seven (7) copies to:
Office of Radiation Safety Services
Medical Sciences Building
Room A-534
Extension 5305
Date approved by:
__________________________________
Human Use Subcommittee
__________________________________
Radiation Safety Committee
(Expires 12 months from
the date of approval)
(Please include (1) copy of the Institutional Review Board (IRB) Application.
____________________________________________________________________________________________
1.
Title of Study:
2.
Principal Investigator (Name, department, title, office address, phone):
Co-Investigator(s) (Name, department, title, office address, phone):
All rooms in which isotopes are to be used:
3.
4.
Radioisotope to be used: _____ _____________________________________________
a.
Total amount to be purchased in next 12 months:
b.
Maximum amount to be purchased as of calibration time:
c.
Maximum amount to have on hand at any one time:
d.
Chemical form (list all compounds): ________________________________________________
e.
Physical form: ________________Solution:_________________________________________
Will isotope be received pre-calibrated and pre-assayed for pharmaceutical quality? ________If not,
describe preparation, assay and calibration procedures including sterility and pyrogenicity testing
procedures if applicable. (Attach additional sheets if necessary).
Rutgers Environmental Health & Safety, Office of Radiation Safety Services
185 South Orange Avenue, MSB A-534 • Newark, NJ 07101-1709 • Phone: (973) 972-5305 • Fax (973) 972-6498 • Web http://rehs.rutgers.edu
The University is an affirmative action/equal opportunity employer
Application for Investigational Human-Use of
Radioisotopes/Radiographic machines
5.
Purpose of study (attach additional sheets if necessary)
___ Established medical use (as defined by the NRC in 10 CFR 35.100 Schedule A)
___ Clinical efficacy trial (IND No.
)
___ Basic research
6.
Plan of investigation (attach additional sheets if necessary)
7.
Complementary drugs or radioisotopes to be administered (if any)
8.
Expected fate of the radioisotope. If a therapeutic procedure, what are the expected effects?
9.
Background. Give pertinent references and a brief abstract of published and/or unpublished material
including data on localization, effective half-life, and radiation dosage. Include data obtained in experimental
animals; if no animal work has been conducted, explain.
10. Description of subjects
a.
Controls: number, age range, method of selection
b.
Experimental subjects: number, age range, nature of pathology, and method of selection.
c.
If pregnant women, minors, or mentally retarded persons are to be studied explain rationale.
11. Please confirm that the consent of the subject or his/her representative will be obtained and attach a copy
of the Consent form.
12. Administered activity (microcuries or millicurie):
a.
Route of administration:
b.
Maximum amount to be given at any one time:
c.
Possible repeat doses within one year:
d.
Total administered activity:
e.
Rationale for the administered activity used:
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Consent Version 4 2013/07/04
Protocol Version 4 2013/07/04
Short Title: __________________
PI Name: ___________________
Application for Investigational Human-Use of
Radioisotopes/Radiographic machines
13. Calculation of radiation absorbed dose (mGy), equivalent dose (mSv), and effective dose (mSv)
a.
Total body:
b.
Critical organs (gonads, lens of eye, red marrow):
c.
Other organs:
From a single scan, the subject will receive
Dose to the gonads =
Dose to the Marrow =
Dose to the lens =
Dose to the urinary bladder wall =
Total body dose =
Effective dose =
Effective dose from low dose CT scan =
Dose to the urinary bladder wall from CT scan =
mSv
mSv
mSv
mSv
mSv
mSv
mSv
mSv
From multiple scans (no. of scans = ), the subject will receive
Dose to the gonads =
Dose to the Marrow =
Dose to the lens =
Dose to the urinary bladder wall =
Total body dose =
Effective dose =
Effective dose from low dose CT scan =
Dose to the urinary bladder wall from CT scan =
mSv
mSv
mSv
mSv
mSv
mSv
mSv
mSv
From single radionuclide injection:
mCi
Dose to the gonads =
Dose to the Marrow =
Dose to the lens =
Dose to the urinary bladder wall =
Total body dose =
Effective dose =
Effective dose from low dose CT scan =
Dose to the urinary bladder wall from CT scan =
From multiple radionuclide injections (no. of injections:
Dose to the gonads =
Dose to the Marrow =
Dose to the lens =
Dose to the urinary bladder wall =
Total body dose =
Effective dose =
Effective dose from low dose CT scan =
Dose to the urinary bladder wall from CT scan =
mSv
mSv
mSv
mSv
mSv
mSv
mSv
mSv
)
mCi
mSv
mSv
mSv
mSv
mSv
mSv
mSv
mSv
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Consent Version 4 2013/07/04
Protocol Version 4 2013/07/04
Short Title: __________________
PI Name: ___________________
Application for Investigational Human-Use of
Radioisotopes/Radiographic machines
From the participation in the study while undergoing (no. of scans = ) scans and radionuclide injections
(no. of injections = ), the subjects will receive total effective dose of
mSv. Total dose to the
critical organ (name of the critical organ =
) will be
mSv.
As per CFR 361.1 (3) (i) - Under no circumstances may the radiation dose to an adult research subject
from a single study or cumulatively from a number of studies conducted within 1 year be generally
recognized as safe if such dose exceeds the following:
Whole body, active blood-forming organs, lens of the eye, and gonads:
Single dose < 30 mSv;
Annual and total dose < 50 mSv
All other organs:
Single dose < 50 mSv;
Annual and total dose < 150 mSv.
d.
Radiation absorbed dose, equivalent dose, and effective dose from other isotopes given concurrently and/or
radiologic imaging procedures to be performed in addition to those required for routine medical care.
14. Institutional resources and radiation safety:
a.
Physical facilities and equipment for study:
b.
Facilities for handling radioisotopes, i.e. monitoring and measuring equipment, shielding, hood, etc.:
c.
Procedures to be used to survey for radioactive contamination. (Note: For radioactive contamination
resulting from work involving low energy beta emitters, dry smears of the area should be taken and
counting should be done in a liquid scintillation counter.)
d.
Procedures to be used for monitoring of personnel:
e.
What plans have been made for decontamination in case of accident?
f.
What plans have been made for sudden critical illness or death of radioactive patient?
g.
What plans have been made for waste disposal (gas, liquid, solids, and animals)? NRC and State
regulations require written records of the disposition of all isotopes received by you. Please refer to the
Radiation Safety Policy Manual for proper disposal procedures.
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Consent Version 4 2013/07/04
Protocol Version 4 2013/07/04
Short Title: __________________
PI Name: ___________________
Application for Investigational Human-Use of
Radioisotopes/Radiographic machines
15. Research Training and Experience:
a.
List research training and experience of all investigators and technical staff responsible for handling
radioisotopes and radiographic machines, including pertinent training and experience in the use of
isotopes/machine.
b.
Name all persons who will use or be exposed to radiation from radioisotopes/machine. The following
individuals have been instructed in the radiation protection associated with this isotope/machine and in
appropriate precautions to minimize exposure:
16. Estimated duration of study: ___________________________________________________
17. Reports:
An annual report for each protocol approved by the Human Use Subcommittee shall be submitted. This report
should include the following:
(1)
(2)
(3)
(4)
Title of the research project
Brief description of the purpose of the research project
Name of the investigator responsible
Pharmacological dose:
(a)
Active ingredients
(b)
Maximum amount administered per subject
(5) Name of the radionuclide(s) used, including any present as significant contaminants or impurities.
(6) Radiation absorbed dose, equivalent dose, and dose equivalent. Provide the absorbed dose and equivalent
dose to the whole body and each organ specified in the protocol that was received by a representative
subject and the calculations or references that were used to estimate these maximum dose commitments.
Also include effective dose. The report shall include the dose contribution of both the administered
radionuclide(s) and x-ray procedures associated with the study. If the study elicits data on the uptake or
excretion of the radioactive drug pertinent to dosimetry, report the mean value and range of values. For
each subject provide:
(a) Age, sex and approximate weight
(b) Total activity of each radionuclide administered for each radioactive drug used in the study.
Report each x-ray procedure used in conjunction with the study.
(c) If the subject has participated in other radioactive drug research studies, report the name of the
radioactive drug used in these other studies, the date of administration, and the total activity of
each radionuclide administered. If any x-ray procedures were used, identify the x-ray
procedure(s) and include an estimate of the absorbed radiation doses.
(d) If more than one administration of a radioactive drug per subject, radiation absorbed dose and
equivalent dose, expressed as whole body, active blood-forming organs, lens of the eye, gonads,
and other organ doses from the administered radionuclides. Also provide effective dose.
(7) A claim of confidentiality, if any
Note: Contents of these reports will be made available for public disclosure unless confidentiality is
requested by the investigator and it is adequately shown by the investigator that the report constitutes a
trade secret or confidential commercial information.
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Consent Version 4 2013/07/04
Protocol Version 4 2013/07/04
Short Title: __________________
PI Name: ___________________
Application for Investigational Human-Use of
Radioisotopes/Radiographic machines
18. Signature below affirms that the responsible investigator shall notify the Human Use Subcommittee
immediately of any adverse reactions possible attributable to radio pharmaceuticals administered and
shall comply with the regulations set forth by the Radiation Safety Committee in the use of radioisotopes.
In case of prolonged absence or termination, the Office of Radiation Safety Services must be notified at Ext. 25305 or E-Mail: orss@ca.rutgers.edu
__________________________________________
Signature
Please Note:
The Office of Radiation Safety Services is available for consultation in calculation of radiation doses
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Consent Version 4 2013/07/04
Protocol Version 4 2013/07/04
Short Title: __________________
PI Name: ___________________